Pharsight

1. Pizensy patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10806743	BRAINTREE LABS	Method of administering lactitol to reduce plasma concentration of lactitol	May, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 12, 2025

NCE-1 date: 13 February, 2024

Market Authorisation Date: 12 February, 2020

Treatment: Method of treating chronic idiopathic constipation in adult patients.

Dosage: FOR SOLUTION;ORAL

Strength	Dosage	Availability
10GM	FOR SOLUTION;ORAL	Discontinued

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6946149	BRAINTREE LABS	Salt solution for colon cleansing	Mar, 2023 (1 year, 1 month ago)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-315)	Aug 05, 2027
New Combination(NC)	Aug 05, 2013

Market Authorisation Date: 05 August, 2010

Treatment: Gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
17.5 g/3.13 g/1.6 g	08 Nov, 2010	1	23 Feb, 2017	07 Mar, 2023	Eligible

Strength	Dosage	Availability
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION;ORAL	Prescription

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11033498	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (13 years from now)
US11638697	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (13 years from now)
US10143656	BRAINTREE LABS	Solid oral sulfate salt formulations for cleaning a colon and methods of using same	Aug, 2037 (13 years from now)
US11382864	BRAINTREE LABS	Solid oral sulfate salt formulations for cleansing a colon and methods of using same	Aug, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 10, 2023

Market Authorisation Date: 10 November, 2020

Treatment: Gastrointestinal tablets indicated for cleansing the colon in preparation for colonoscopy

Dosage: TABLET;ORAL